DE102019107540A1 - Monitoring system for a blood treatment device for monitoring particularly hygiene-relevant conditions - Google Patents

Abstract

The present invention relates to a system with a blood treatment device (4) and with a monitoring system (1000) for monitoring the occurrence of a condition (Zx) (x = 1, ..., n) from a group with predetermined conditions (Z1, .. ., Zn), for which it was previously defined or determined that, when they occur, the user of the blood treatment device (4) must wear, include or consist of gloves with the aim of avoiding contamination or the spread of germs.

Description

The present invention relates to a monitoring system according to the preamble of claim 1 and a system according to the preamble of claim 6. Furthermore, the present invention relates to a digital storage medium according to claim 8, a computer program product according to claim 9 and a computer program according to claim 10.

In the treatment of patients, special attention is paid to avoiding infections between patients treated simultaneously or one after the other in the same clinic or on the same ward. Are medical devices such as B. used blood treatment devices, it is necessary to monitor that they are not a source of infections in the future or patients treated at the same time.

The object of the present invention is to propose a monitoring system for a medical device, in particular a blood treatment device, and a system suitable for monitoring, as well as a digital storage medium, a computer program product and a computer program.

The object according to the invention is achieved by the monitoring system with the features of claim 1 and by the system with the features of claim 6.

It is also achieved by means of the digital storage medium with the features of claim 8, the computer program product with the features of claim 9 and the computer program with the features of claim 10.

In all of the above and following statements, the use of the expression “can be” or “can have” etc. is to be understood as synonymous with “is preferably” or “preferably” etc. and is intended to explain an embodiment according to the invention.

Whenever numerical words are mentioned here, the person skilled in the art understands them to indicate a numerically lower limit. If this does not lead to a contradiction that is noticeable to the person skilled in the art, the person skilled in the art therefore always reads “at least one” or “at least one” when indicating “a” or “an”. This understanding is also encompassed by the present invention, as is the interpretation that a numerical word such as “a” can alternatively be meant as “exactly one” wherever this is technically possible for the person skilled in the art. Both are encompassed by the present invention and apply to all numerical words used herein.

When “programmed” or “configured” is mentioned here, it is also disclosed that these terms can be exchanged for one another.

If the person skilled in the art has doubts, the information “above” and “below” are to be understood here as absolute or relative spatial information relating to the orientation of the component in question during its normal use.

The monitoring system according to the invention is used to monitor whether a predetermined state is present, is occurring or is about to occur during or in connection with the use of a medical device, in particular a blood treatment device. If this is the case, one or more actions are automatically initiated by the monitoring system with the aim of contributing to patient safety.

Predetermined states are characterized by the fact that for them in advance - z. B. based on experience, legal regulations, etc. - at the factory, by the clinic, the ward or the user of the blood treatment device (mostly medical or nursing staff) it has been determined that when it occurs, with the aim of avoiding contamination, cross-contamination (a Transfer of germs from one patient to another or from one blood treatment device to another) or germs carried over by the monitoring system, predetermined actions are to be taken or brought about. For these states it can apply that when they occur z. B. gloves are to be put on or worn by the user of the blood treatment device or worn gloves are to be changed or taken off. So it can be determined that when such a state occurs, the user has to wear gloves for pending activities in connection with the blood treatment device or another medical device or - z. B. after an activity of the user in which he wore gloves - must be taken off.

The predetermined state is defined or circumscribed in advance by means of specific features, as explained further below. Since a number of conditions can arise during the treatment, for which the wearing of gloves may be prescribed, in practice a group of such conditions, i.e. optionally more than just one such condition, is preferably compiled and stored.

In this context, monitoring can alternatively be understood to mean recognizing, further alternatively indicating that such a state is present has occurred or is about to occur, or combinations thereof.

According to the invention, the monitoring system that is used for such monitoring comprises at least one suitably programmed or configured memory device, detection device, receiving device and execution device. These devices can be embodied by means of individually present components or implemented in practice in any combination in common components.

The group with the at least one predetermined state is stored in the storage device. For each of these states of the group, at least one predetermined signal configuration and at least one predetermined action in response to a signal can be assigned in this configuration.

In addition or as an alternative, a specification, description, definition or entry condition of the state can be stored in the memory device for each of the states of this group. The terms definition, description, definition or entry condition can in some embodiments replace the term “definition” used below, and vice versa.

The predetermined conditions which the group comprises or of which it consists can be conditions related to the use of a blood treatment device ( Z ₁ , ..., Z _n ) be.

The determination device is configured to determine that or whether at least one of the conditions defined in the group has occurred. For this purpose, it can optionally have at least one suitable sensor or it can be based on sensor results from existing sensors, e.g. B. the blood treatment device to fall back. The determination device is further configured to send, in the event that it determines that one of the defined states has occurred, a signal that is associated with the determined predetermined state, specifically in the configuration associated with this state. The determination can be or comprise measuring, comparing, reading out, evaluating and / or calculating.

The receiving device is configured to receive the transmitted signal and, when it is received, to initiate at least one predetermined action assigned to the signal by means of an execution device.

The execution device is configured in order, when it receives such a signal from the receiving device, to carry out the action which is respectively associated with the transmitted signal in the storage device.

The whole group of states ( Z ₁ , ..., Z _n ) only one signal and, associated with it, the same action in each case. This can also be done for some of the states from the group ( Z ₁ , ..., Z _n ) so apply. The signal-action combinations that correspond to the individual states Z _x from the group ( Z ₁ , ..., Z _n ) do not necessarily have to differ from one another.

According to the invention, a system is also proposed which, in addition to the monitoring system according to the invention, has a medical device, in particular a blood treatment device.

An inventive, in particular digital, in particular non-volatile, storage medium (also referred to here as a carrier), in particular in the form of a diskette, RAM, ROM, CD, hard drive, DVD, USB stick, flash card, SD card or EPROM, in particular with electronically or optically readable control signals, programmed to program or configure a blood treatment device, which has a memory device, a detection device, a receiving device, and an execution device, to form a system according to the invention is also proposed.

A computer program product according to the invention has a volatile, volatile or program code stored on a machine-readable carrier, by means of which a blood treatment device, which has a storage device, a detection device, a receiving device, and an execution device, can be programmed or configured into a system according to the invention.

In certain embodiments of the present invention, the term “machine-readable carrier” as used herein denotes a carrier that contains data or information that can be interpreted by software and / or hardware. The carrier can be a data carrier such as a diskette, a CD, DVD, a USB stick, a flash card, an SD card, an EPROM and the like.

A computer program according to the invention has a program code by means of which a blood treatment device, which has a memory device, a detection device, a receiving device, and an execution device, can be programmed, reprogrammed or configured into a system according to the invention.

According to the invention, a computer program product can be, for example, a computer program stored on a carrier, an embedded system as a comprehensive system with a computer program (e.g. an electronic device with a computer program), a network of computer-implemented computer programs (e.g. client / server system , Cloud Computing System, etc.), or a computer on which a computer program is loaded, runs, is stored, executed or developed.

According to the invention, a computer program can be understood to mean, for example, a physical, marketable software product which has a program.

Advantageous further developments of the present invention are each the subject matter of subclaims and embodiments.

When an embodiment is mentioned here, this is to be understood as a purely exemplary embodiment according to the invention.

Embodiments according to the invention can have one or more of the features mentioned above and / or below in any combination, unless the person skilled in the art recognizes the specific embodiment as technically impossible.

A predetermined state within the meaning of the present invention, if recognized by the locking device, can be a trigger for a signal which the locking device sends out based on the signal configuration stored in the memory device for this state.

A “definition” can generally be a description, e.g. B. an observation, a sensor result or a machine behavior (z. B. treatment sequence, read out from control software).

A description can e.g. B. be: “User is not wearing gloves”, “User has approached the blood treatment device”, etc. A machine behavior can e.g. B. be: The control or regulating device (for short: control device) causes the blood treatment to be ended, that pumps are stopped and / or that the blood treatment device goes into reinfusion, that a "blood leak alarm" was triggered, that a message such as "Patient must be connected" is output, etc.

A predetermined action can be assigned to each such definition, for example according to an IF-THEN rule (IF, for example, a blood leak alarm is triggered, THEN, for example, the message that gloves must be put on is also issued). This is associated with the definition of the type of signal that triggers the action, namely z. B. a signal that is transmitted to a monitor, and which allows this to display a specific, predetermined text as a hint for the user.

Associated with a definition can be that e.g. B. a tick or a marker has been set in software for certain states. In this way, the manufacturer, the technician and / or the user can determine which states that can occur when using the blood treatment device count as a state of the group mentioned herein.

In some embodiments, the execution device is or comprises at least one monitor, a screen or a display configured to display a message corresponding to the signal to the user of the treatment device. This monitor can be part of the blood treatment device, it can be a separate monitor.

In some embodiments, the execution device is or comprises a hand-held device that is intended to be held and / or carried by the user.

Such handheld devices include smartphones, blackberries, pagers, beepers, clips, pendants, headsets, smart watches or wrist devices, etc.

The execution device can have the receiving device and is preferably in signal connection with the locking device therein.

In some embodiments, the execution device is or comprises the control or regulating device of the blood treatment device or a section thereof. For example, the control or regulating device of the blood treatment device can be configured to stop pumps as a predetermined action when a signal is received that is assigned to one of the predetermined states from the group with the hygiene-relevant states, as a predetermined action on the treatment device , etc. This intervention of the control or regulating device in the treatment process can continue until the monitoring system detects that the user is wearing gloves, until the user confirms a message, and / or until another, likewise predetermined, circumstance occurs.

In some embodiments, the action is or includes the executing device upon receipt of the signal assigned to the predetermined state causes the output of a predetermined message on the execution device, e.g. B. the monitor or the display.

Alternatively or in addition, the action is or includes causing a component to vibrate, outputting predetermined color representations, outputting an optical or acoustic alarm, requiring confirmation by the user before he or she B. can continue with the use of the treatment device or predetermined options of treatment.

The action can further include saving a history. The history can provide information about the times and / or the frequency of occurrence of messages, notices or alarms in connection with states from the group, in particular by specifying a weighting, relevance or evaluation. Such a history can be used for further training of the staff and / or for quality assurance.

• - das Überwachungssystem erkennt, dass der Nutzer hintereinander an zwei vorab als hygienerelevant eingestuften medizinischen Geräten, insbesondere Blutbehandlungsvorrichtungen, tätig ist;
• - das Überwachungssystem erkennt einen Alarmzustand (Alarm, ausgegeben etwa durch den Dichtesensor, optischen Sensor, Luftsensor, Drucksensor, Blutdetektor, Zugangssensor oder einen anderen Sensor der Blutbehandlungsvorrichtung);
• - das Überwachungssystem erkennt einen vorbestimmten Betriebsablaufschritt an der Blutbehandlungsvorrichtung, etwa Primen; anstehendes Verbindens des Patienten; Erhöhen des Flusses mittels der Blutpumpe; Änderungen eines gemessenen Drucks; Trennung des Patienten; Betätigen oder Auswählen eines Schalters; Stoppen einer vorbestimmten Pumpe;
• - das Überwachungssystem erkennt das Eintreten des Nutzers in eine vorbestimmte, die Blutbehandlungsvorrichtung zumindest abschnittsweise umgebende Zone oder das bevorstehende Eintreten, oder ein Verlassen derselben oder ein anstehendes Verlassen derselben durch den Nutzer.

In certain embodiments, the following observations or events count as a condition:

• the monitoring system recognizes that the user is working one after the other on two medical devices, in particular blood treatment devices, which have been classified as hygiene-relevant in advance;
• the monitoring system detects an alarm condition (alarm, issued for example by the density sensor, optical sensor, air sensor, pressure sensor, blood detector, access sensor or another sensor of the blood treatment device);
• the monitoring system recognizes a predetermined operating sequence step on the blood treatment device, for example priming; pending connection of the patient; Increasing the flow by means of the blood pump; Changes in measured pressure; Separation of the patient; Actuating or selecting a switch; Stopping a predetermined pump;
• the monitoring system detects the entry of the user into a predetermined zone surrounding the blood treatment device at least in sections or the imminent entry, or an exit from the same or an upcoming exit from the same by the user.

In some embodiments, the detection device is a sensor, software, routine, program loop or a portion thereof, a camera, a touchscreen capacitance meter and / or a zone monitoring device.

The following statements indicate embodiments for implementing the present invention. In particular, they relate to the definition of predetermined states, e.g. T. with associated actions.

The knowledge that the user is in a certain phase of the preparation of the blood treatment device for the upcoming treatment session can be regarded as a predetermined state (and accordingly be stored as a state in the memory device and its occurrence is read out e.g. by the detection device from the operating software) or has to handle the blood accesses himself during the blood treatment. Examples are given below.

A state can e.g. B. when connecting the patient (device is e.g. in priming mode), when disconnecting the patient (device is e.g. in reinfusion mode or afterwards), or in special alarm situations in which it It is likely that the user has or will have contact with the blood tubes / access points or other hygiene-relevant components.

For monitoring the connection of the patient, the monitoring device can optionally be configured as follows: The blood treatment device optionally has a menu item on the GUI (Graphical User Interface), there the phase can either be displayed automatically or selected by the user. Accordingly, the blood treatment device is in the “priming mode” or a preparation mode until it is no longer selected. With automatic detection of the end of this phase by means of appropriate software, the blood treatment device can have a sensor, for example an optical detector (IR) and / or a density detector (ultrasound), which indicates when blood is flowing in the arterial line. For this purpose, the detector can optionally determine the properties of the fluid contained therein on the arterial or venous tube. Alternatively or in addition, starting / increasing the blood flow (corresponding to a set value or a directly / indirectly measured flow) above a limit value can be used as a criterion, because it is not to be expected that the user will disconnect before a clean connection of lines Flow increased.

A pressure value in the hose system can therefore also be used, since this naturally depends on the blood flow (rotation of the pump). Conveying the knowledge that one of these States that require action can be transmitted by the software (which is provided, for example, to regulate the blood treatment device) via a signal to the detection or receiving device.

To monitor the reinfusion of the blood after the treatment, it can be configured that the monitoring system recognizes the end of the treatment, for example by the blood treatment device recognizing that a prescribed ultrafiltration amount has been withdrawn from the blood or that a predetermined treatment time has expired. For this purpose, the monitoring system can be configured as follows: The blood treatment device can have a menu item on the monitor, e.g. B. the GUI (Graphical User Interface). There it can be provided to either display the phase (reinfusion phase) automatically or to leave it to the user for selection. If the blood treatment device changes to one of these phases due to a user input or automatically, this can be predetermined as a state for which an action and thus also a signal triggered by this action are stored in the memory device. The action can consist in outputting a message that gloves must be worn for the next activities on the blood treatment device. Alternatively or in addition, other or further actions are also conceivable.

For monitoring the separation of the patient, for example after the so-called reinfusion phase or a dependency phase following the reinfusion, in which the patient is separated and / or bags etc. are removed, the monitoring system can optionally be configured as follows: The blood treatment device can have a menu item on the monitor, e.g. B. the GUI (Graphical User Interface). It can be provided there to either display the phase (for example, the dependent phase) automatically or to leave it to the user for selection. If the blood treatment device changes to one of these phases due to a user input or automatically, this can be predetermined as a state for which an action and thus also a signal triggered by this action are stored in the memory device. The action can consist in outputting a message that gloves must be worn for the next activities on the blood treatment device. Alternatively or in addition, other or further actions are also conceivable.

For an automatic start of this phase, the blood treatment device can have a sensor, for example an optical detector (e.g. IR), a density detector (e.g. ultrasound), etc., which indicates when there is no or largely no more blood in the venous line flows. For this purpose, the detector on the venous tube can determine the properties of the fluid contained therein. Alternatively, a pressure value in the hose system can also be used, since the blood pump is stopped at the end of the reinfusion phase and the pressure in the overall fluid system is equalized.

Alternatively or in addition, it can also be recognized that a specified treatment time has expired. This can also be stored as a predetermined state; here, too, it can be assumed that the user will next disconnect the patient from the patient lines and z. B. will supply the puncture sites.

For example, it can be programmed not to assume that the patient will be disconnected as long as the optical sensor, e.g. B. for optical density, does not show a change from "dark" to "light". It can be provided that no message is sent to the user and / or no status is stored in the event that there is no recognizable change in the fluid flowing in the extracorporeal blood circuit (ie no change in the optical density from "light" to "dark") "Or from" dark "to" light "), that is, blood is not displaced by transparent rinsing fluid in the direction of the patient's venous needle, and / or no fluid below a specified density etc. is displayed.

Furthermore, predetermined states can be stored, when they occur it is likely that the user has or will have contact with the blood tubes / accesses.

In some embodiments it is provided that an action that has already been initiated is reversed or ended in the event that the state should no longer last. This can be programmed, e.g. B. in the event of an alarm as a predetermined state a notice already displayed on the monitor (z. B. via the GUI), according to which, for example, gloves are to be put on, worn, changed or taken off, no longer displayed. Since the alarm case, which is considered a predetermined state, no longer applies, a corresponding notice or other action may no longer be required. The same can apply if z. B. a pump stopped in the context of an alarm condition has started again, the alarm condition thus no longer exists.

Another predetermined condition can occur when an arterial negative pressure alarm (indicates suction of the needle in the vessel) is detected. The monitoring system can optionally be configured as follows: The device has a so-called arterial pressure sensor. This is arranged in such a way that it measures the pressure in the area of the tube near the arterial needle (for example between the needle and the blood pump). If this pressure falls below or to a predetermined limit value, this is interpreted as a problem with the arterial access. In order to remedy this error state, it must be expected that the user will come into contact with the vascular access or the tubes.

Another predetermined condition can occur if a “Venous Access Monitoring Alarm” (indicates loss of the venous needle) occurs. The monitoring system can optionally be configured as follows: The device has a so-called venous pressure sensor. This is arranged in such a way that it measures the pressure in the area of the tube near the venous needle (for example on a venous blood chamber). If, on the basis of this pressure, a disconnection of the needle or a loosening of the connection needle / hose is concluded, this pressure falls below or to or around a predetermined limit value, as is the case e.g. B. Subject of WO 2009/118145 A1 is. Alternatively, other methods for checking a needle disconnection and its alarm signals can also be used as triggers. Such procedures may involve moisture sensors at the puncture site, such as B. Subject of WO 2011/116943 A1 is, optical methods such as e.g. B. Subject of WO 2008/123814 A1 or electrical methods such as e.g. B. Subject of WO 2003/086505 A1 is to act. In order to remedy this error state, it must be expected that the user will come into contact with the vascular access or the tubes. The disclosures of the aforementioned documents are hereby made the subject of this disclosure in their entirety by reference. They can in particular serve as examples for the description of predetermined states of the group.

Yet another predetermined condition can occur when a blood leak detector alarm occurs. The monitoring system can optionally be configured as follows: The blood treatment device has a so-called blood leak detector. This is a detector that is arranged downstream of the dialyzer or blood filter on the dialysate drain line and can detect even small amounts of blood. This is usually done optically. The detection device of the monitoring system according to the invention can be configured to send a corresponding signal when a blood leak is detected, upon receipt of which the execution device triggers or initiates an action (notification, alarm, etc.) assigned to the case of a blood leak.

Yet another predetermined condition can occur when an air alarm / microbubble alarm occurs. In this case, it may be necessary for the user to disconnect the patient in order to remove the air from the system. The monitoring system can optionally be configured as follows: The blood treatment device optionally has one or more so-called air detectors. These are detectors that are arranged on a blood line. This is usually done using ultrasound, but can also be done using electrical or optical methods. If this hits, it may be necessary for the user to loosen adhering air bubbles, for example by moving the hoses, or even to disconnect the patient. In this case, it can be stored that gloves must be worn. The air alarm / microbubble alarm can be defined as a predetermined state which triggers a predefined signal and an associated action, as stored in the memory device.

Yet another predetermined state can occur when entering a predetermined zone (for example around the blood treatment device) or leaving this zone is recognized by a user or by any person in general. Such a state is comparatively easy to determine by means of methods that allow spatial resolution in order to identify a person located there. Such methods can, for example, include or be based on triangulation (with WLAN, IR, RFID), temperature sensors, cameras, motion detectors, etc.

When putting it into practice, the necessary upstream and downstream equipment (sensors, cameras, etc.) do not necessarily have to be installed on the device; they can also be located elsewhere in the room to be recorded.

For example, a 1 m wide space around the blood treatment device can be defined as a zone whose entry (or exit, since the user may have made his way to the next patient when leaving the zone) is stored as a predetermined state and its detection can trigger the corresponding signal.

The defined zone can be symmetrical. It can be asymmetrical. It can be, for example, 1 m in the direction of the patient's bed, but only 40 cm in the direction of an adjacent blood treatment device. Markings (optionally removable) can be used in the room to define the zones.

Preferably, according to the invention, it is advantageously not always pointed out, regardless of the upcoming activities of the user, that Gloves are to be changed or taken off, but preferably only on certain occasions, namely when one of the predefined and thus previously recognized as particularly hygiene-relevant conditions occurs. This restriction to the particularly hygiene-relevant conditions can advantageously a) prevent the user from becoming blunted with regard to instructions, alarms or other conditions relating to the use of gloves, and b) possibly help reduce the consumption of (not required) gloves.

In some circumstances, however, it may be necessary to ensure a priori that the user is wearing gloves, possibly regardless of which activities are to be carried out directly by him. Such circumstances can e.g. B. dealing with known infectious patients, patients with known colonization by multi-resistant germs, etc.

For such - or other - cases, it may be desirable to check whether the user is wearing gloves. The same applies if you want to check whether the user is e.g. B. has followed an instruction to put on gloves.

For such cases, a possibly further, predetermined state can be stored, which already occurs when it is recognized by the monitoring system that the user is not wearing gloves.

Failure to wear the gloves can be detected by means of suitable sensors that are connected to the locking device or are part of it, e.g. B. optically or by capacitance measurement, heat sensor, etc.

So z. B. can be recognized by means of a touchscreen whether the user is wearing gloves. This is done, for example, by means of the current flowing over the screen or a capacitive signal. The operation of the touchscreen can differ measurably depending on whether the user wears gloves or not.

If the user is not wearing gloves, any action mentioned herein can be considered as the action that is carried out or caused by the execution device when the signal is received.

So z. B. an operation of the blood treatment device, such as the confirmation or termination of an alarm, a message, or already starting the blood treatment, selecting a treatment option, connecting lines, etc. will be impossible if the monitoring system has recognized that the user does not wear gloves.

The locking device can be part of the blood treatment device, but it can also be part of a (further) device of the monitoring device or an independent element.

The locking device is, or has a, transmitter (Bluetooth, WLAN, etc.), with which it connects to the receiving device, e.g. B. a receiver on the bracelet, can communicate directly or indirectly.

In some embodiments, the locking device is arranged in the room (patient room, treatment room, etc.) or building (clinic, ward, dialysis department, etc.).

In some embodiments, the locking device is designed to communicate with the receiving device wirelessly or via a wired connection.

Is the locking device z. B. part of the blood treatment device and / or if it uses its components, this can advantageously contribute to the fact that the present invention can be implemented in or on blood treatment devices that are already in use. So it may be sufficient to use the operating software of the blood treatment device by means of, for. B. update the computer program according to the invention, which is inexpensive and simple.

This can be the case in particular if the predetermined state is a machine behavior of the blood treatment device in the course of the blood treatment, for example the transition to reinfusion or the like, or if the predetermined state is an alarm state of the blood treatment device, and if, in addition, the execution device is the monitor of the Is a blood treatment device that outputs appropriate messages such as "Wear gloves!" As an action to the user.

The executive device, in some embodiments, is an alarm device.

In some embodiments, the execution device is or has a monitor.

In some embodiments, the execution device can be worn on the body, preferably on a wristband and thus close to the glove and / or easily visible and / or actuatable, for example to confirm a message on a monitor or to switch off a vibration alarm or an acoustic alarm. In addition or as an alternative the execution device can be a clip, a tag, etc.

In some embodiments, the execution device is configured to generate a vibrating alarm, a visual and / or an audible alarm.

A visual alarm can be color-coded (e.g. two colors, e.g. red and green, where red can indicate that the user has something to do). A color coding such as B. the use of red light, or light in different colors, like - with the possible exception of the pure vibration alarm - also other forms of alarm can be recognized by an outsider (i.e. a person other than the responsible user).

Other signals such as different brightnesses, interrupted light versus continuous light, sound (volume, frequency) etc. are also possible according to the invention.

In some embodiments, the execution device is configured to output further information in addition to the aforementioned alarm relating to putting on, wearing, changing and / or taking off gloves, e.g. B. by means of the monitor or display that the user z. B. on the bracelet. For this additional information z. B. Count alarms associated with other medical devices.

The execution device can be part of a further medical device, for example a further blood treatment device. It can thus be known which device the user will be working on next.

In some embodiments, the execution device is configured to, upon confirmation of the indication that e.g. B. to put on, wear, change or take off gloves to end an alarm for third parties (patients, doctors, other nurses) by z. B. a color marking similar to a traffic light switches from "red" to "green". In this way, it is also possible for third parties to recognize that hygiene measures are required or have been carried out. This advantageously enables the user to be checked by third parties. In this way, even the patient can point out the necessary hygiene measures or the hygiene protocol to the stressed or inexperienced user, which can increase patient safety.

In some embodiments, the monitoring system is configured to maintain a history of the behavior of the monitoring system, e.g. B. to save their locking device or their execution device. So, to stick with the previous example, e.g. B. the information how often the color marking was "red", or how long it was "red", or any other type of action can be stored, for example in the memory device. Reading out this storage can then be used, for example, to increase patient safety, in that the user can be addressed or further trained based on the stored data with a view to the hygiene protocol. The storage device used for this purpose can be part of the blood treatment device, part of a server in the clinic, ward or the like, or an independent storage device.

The history can advantageously also be used here in order to assign certain incidents to certain people. For this purpose, it is conceivable that the blood treatment device recognizes the respective user and can assign “his” alarms to him. Several methods are conceivable for this: a) the user has to identify himself at the blood treatment device, e.g. B. by active insertion, e.g. B. a chip card; b) the user is automatically recognized by the blood treatment machine, for example by means of RFID, NFC chip, tags, GPS transmitters, cell phone location, barcode recognition, face recognition or the like.

Devices for identification can be integrated into the blood treatment device or configured to communicate with it. One example is face recognition by camera in combination with device identification. This can be particularly relevant as it can contribute to better monitoring of personnel and thus to quality assurance, especially in the event of a hectic alarm.

In some embodiments, a device of the monitoring system, e.g. B. the detection device or the execution device, configured, if it is recognized by the monitoring system that the user is leaving the zone, to only take an action, and in particular to issue a message only if in connection with an activity carried out on the blood treatment device, whose surroundings or zone the user is about to leave, it was recognized that gloves were being worn. B. take off or change applies. This can be detected in any of the ways described herein, e.g. B. by means of the touch screen of the blood treatment device whose zone the user is about to leave.

In some embodiments, a device of the monitoring system, e.g. B. the detection device or the execution device, configured as follows: If it is recognized by the monitoring system that the user at a first medical device has performed an activity for which the wearing of gloves is prescribed, but at the same time the monitoring system cannot determine that he was wearing gloves on the first medical device, a corresponding action is carried out by means of the monitoring system. For example, it can be pointed out that gloves must be worn and / or hand disinfection must be carried out.

The monitoring system can additionally be configured so that the action is only carried out if a second blood treatment device will have to be operated according to a stored work plan and / or if it is recognized by means of a detection device, for example a camera or a detection device as described above, that a predetermined blood Area around a second blood treatment device is entered.

A treatment device according to the present invention can be suitable and / or configured for performing a hemodialysis, a hemofiltration, a hemodiafiltration or a separation method, without being limited thereto.

In some embodiments, the invention is not directed to a blood treatment device, but rather to a medical device, the use of which is also expected to result in the user of the device wearing gloves. Such devices can also be treatment devices, but they can also be dialysis devices or serve some other purpose. For these embodiments, what is stated herein about blood treatment devices applies analogously to the medical device. In these embodiments, the terms “blood treatment device” and “medical device” can thus be interchangeable.

One or more of the advantages mentioned herein can be achieved by means of some embodiments.

One advantage of the invention is that it is very easy to implement. It may thus be possible to convert a conventional blood treatment device into a blood treatment device according to the invention simply by means of a software update. The output of information or glove alarms, for example on the user's smart phone carried in the pocket, or the room alarm or machine alarm via vibration alarm or by means of an alarm or ring tone reserved for this purpose, can be implemented without significant technical effort.

The present invention can contribute to advantageously avoiding the spread of germs between patients or between blood treatment devices, or at least reducing their risk. This advantage is likely to come into play especially for inexperienced users.

In addition, the present invention allows different hygiene protocols to be followed within a clinic or ward and even within a patient room with more than one patient. Thus, it can be provided that a first monitoring device for monitoring a first patient (or a first blood treatment device) has access to a first group of conditions, and a second monitoring device for monitoring a second patient (or a second blood treatment device) for a second group of conditions. Both the first blood treatment device and the second blood treatment device can be used on the same ward or in the same patient room. If the states which their execution devices access differ from one another, they instruct the users of these two blood treatment devices to behave differently in connection with the use of gloves. Such a use of the present invention can offer advantages above all if, for example, from the point of view of possible germ contamination, patients who are harmless are treated together with patients who are highly problematic with regard to their germ load (MRSA or other (multi-) resistant germs) in a room, on a ward, etc. will.

At the same time, the present invention can contribute to reducing the consumption of gloves to a sensible level if the conditions are appropriately selected sensibly.

• 1 zeigt schematisch vereinfacht Abschnitte einer erfindungsgemäßen Blutbehandlungsvorrichtung mit einem erfindungsgemäßen Überwachungssystem in einer beispielhaften Ausführungsform;
• 2 zeigt ein erfindungsgemäßes Überwachungssystem grob vereinfacht als Diagramm; und
• 3a bis 3c zeigen Beispiele für das Eintreten eines vorbestimmten Zustands.

The present invention is explained below by way of example with reference to the accompanying drawing, in which the same reference symbols denote the same or similar components. In the figures:

• 1 shows schematically simplified sections of a blood treatment device according to the invention with a monitoring system according to the invention in an exemplary embodiment;
• 2 shows a monitoring system according to the invention in a highly simplified diagram; and
• 3a to 3c show examples of the occurrence of a predetermined condition.

1 shows an extracorporeal blood circuit 1 , which leads to a treatment using double Needle access, or using, e.g. B. an additional Y-connector, by means of single-needle access, would be connected to the vascular system of the patient, not shown. The bloodstream 1 is optionally in sections thereof in or on a blood cassette 2 in front. This blood cassette 2 is optionally designed to be used in other types of treatment, for example a single needle treatment.

Pumps, actuators and / or valves in the area of the blood circulation 1 are with a blood treatment device according to the invention 4th or with a control and / or regulating device 29 having a monitoring system according to the invention 1000 , or parts thereof, or may be connected to it in signal communication. The surveillance system 1000 includes a locking device 200 or is connected to such in signal communication. The locking device 200 can be a camera, for example.

The bloodstream 1 has an arterial patient hose clamp 6th and an arterial connection needle 5 (as an example of an access device) of an arterial section or an arterial patient line or blood collection line 9 on. The bloodstream 1 also includes a venous patient hose clamp 7th and a venous connection needle 27 (as an example of a further or second access device) of a venous section or a venous patient line or blood return line 23 on.

A blood pump 11 is in the arterial section 9 provided a substituate pump 17th is with a substituate line 17a connected. The substituate line 17a can by means of a, preferably automatic, substituate port 18th be linked to a source of substituate. Using the substituate pump 17th can substitute by predilution or by postdilution via associated lines 13 or. 14th in line sections, for example in the arterial section 9 or in a venous section 23a (between a blood chamber 19a a blood filter 19th and a venous air separation chamber 21st ) of the bloodstream 1 be introduced.

The blood filter 19th assigns those with the arterial section 9 and with the venous section 23a connected blood chamber 19a on. A dialysate chamber 19b of the blood filter 19th is with one to the dialysate chamber 19b leading dialysis fluid supply line 31a and one from the dialysate chamber 19b leading away dialysate drain line 31b connected.

The dialysis fluid supply line 31a optionally has a valve V24 by means of which the flow within the dialysis fluid supply line 31a can be prevented. The dialysate drain line 31b optionally has a valve V25 on, by means of which the flow within the dialysate drain line 31b can be prevented.

The dialysis fluid supply line 31a is also optional by means of a further, machine-internal valve with a compressed air source 26th connected. The compressed air source 26th can be part of the treatment device 4th be or separate therefrom. Downstream of the compressed air source 26th can be a pressure sensor 37 be provided.

1 also shows an arterial air-blood detector 15th , a venous substituate blood detector 25th as well as pressure sensors 33a , b. You can use the locking device ( 200 ) be used.

2 shows a monitoring system according to the invention 1000 to monitor for the occurrence of a certain state ( Z ₁ , ..., Z _n ) roughly simplified as a diagram. The arrows (denoted by B to F, F 'and U) indicate data streams that are used for the above-mentioned monitoring by the monitoring system according to the invention 1000 are necessary. The data can be transmitted via electronic connection, cable or wirelessly.

The division of the individual devices 100 , 200 , 300 , 400 is purely exemplary. They can also be placed in the blood treatment device individually or in groups 4th or another medical device. Any connected combinations of the individual devices are also possible 100 , 200 , 300 , 400 in separate housings or each device individually conceivable. The invention also encompasses some or all of the devices 100 , 200 , 300 , 400 to be provided as software implementations.

The surveillance system 1000 comprises a storage device 100 , which contains definitions or descriptions of previously defined hygiene-relevant conditions Z ₁ , ..., Z _n , here as an example in tabular form. Z each state _x (x = 1, ..., n) in the respective row of the table at least one corresponding signal S _x and at least one, the signal S _x each corresponding action A _x assigned. It is possible to add further data to the table according to the status. It is also conceivable to transfer the data from this table via the data stream A with data from the blood treatment device 4th to update, change and / or expand, for example also in order to save a history as discussed above.

Furthermore, the monitoring system 1000 a locking device 200 on which based on the data stream C. available data, for example sensor or Treatment data of the blood treatment device 4th , including those in the storage device 100 stored states by various operations, as stated above, can determine whether a hygiene-relevant state Z _x from the group Z ₁ , ... Z _n present. In the simplest case, this is done by comparing the stored states Z _x (x = 1, ..., n) with an actual situation.

If this is the case, the locking device sends 200 over the data stream F. the signal S _x assigned to the determined state Z _x to a receiving device 300 . This now directs the action A _x to be carried out which is assigned to the signal and is read out here via the data stream F '(via the data stream B. ) by means of an execution device 400 , here for example a display or another communication device of the blood treatment device 4th , a bracelet, a cell phone, a tablet, a pager, a beeper, etc. for the user's knowledge.

3a shows an example of the occurrence of a predetermined condition Z ₁ and the interaction of the blood treatment device 4th at which the state Z ₁ enters, with a handheld device as an example of an execution device 400 .

In the example of 3a instructs the blood treatment device 4th at least the locking device 200 and optionally also further components of the monitoring system mentioned herein 1000 on.

The execution device 400 of the monitoring system 1000 on the other hand, in the example 3a a handheld device that the caregiver carries with them.

In the left illustration of the 3a is controlled by the locking device 200 no state recognized which belongs to the group of predetermined states Z _x . There is therefore also no signal that would lead to the predetermined action.

This changes shortly afterwards, as indicated by the arrow between the left and right representation of the 3a is indicated.

In the illustration on the right it can be seen that the locking device 200 now the state Z ₁ recognized from the group of predetermined states. This state can be, for example, a blood leak alarm, for which it is stored that fresh gloves are to be worn by the nursing staff in response to this. As a result of the occurrence of this state, the handheld device of the nursing staff z. B. a note as an example of the state Z ₁ assigned action A ₁ , for example, that the gloves need to be changed.

3b shows a further example of the occurrence of a further predetermined state Z ₂ and the interaction of the blood treatment device 4th , at which state Z ₂ occurs, again with a hand-held device as an example of an execution device 400 .

Unlike in the example of 3a instructs the blood treatment device 4th at least the locking device 200 of the monitoring system 1000 not on. The locking device 200 is rather a blood treatment device 4th external device, here as an example a camera or zone monitoring device. It can, as in 3b indicated above the blood treatment device 4th and / or a patient bed next to the blood treatment device 4th be arranged and z. B. a zone indicated by the broken lines and the circle 50 monitor according to predetermined criteria for the occurrence of one of the predetermined conditions.

The predetermined state Z ₂ , which the camera in the transition from the left representation to the right representation of the 3b is that the caregiver has recognized the predetermined, monitored zone 50 leaves or has left.

If the predetermined state Z ₂ occurs, the assigned action A ₂ on the handheld device of the nursing staff z. For example, a notice will now be issued that the gloves previously worn must be changed or discarded.

3c shows yet another example of the occurrence of a further predetermined state Z ₃ and the interaction of the blood treatment device 4th , at which state Z ₃ occurs, again with a hand-held device as an example of an execution device 400 .

Unlike in the examples of 3a or 3b instructs the blood treatment device 4th only part of the locking device 200 of the monitoring system 1000 on.

The locking device 200 is here as a combination of devices, for example for the blood treatment device 4th count, and facilities external to the blood treatment device 4th are as here exemplarily the camera or zone monitoring device of the 3b , to understand.

The so divided locking device 200 must, in order to be able to determine that a predetermined state occurs, both by means of the zone monitoring device a partial state Z ₃ and by means of the blood treatment device 4th recognize another partial state Z ₃ '. Only when both If partial states are considered to have occurred, the nursing staff receives a message or the like, which is referred to here as assigned action A ₃ . This can, purely by way of example, correspond to the above-mentioned action A ₂ , which, however, is only required when on the treatment device 4th z. B. it was found that the patient's vascular access was established (partial state Z ₃ ') and the nurse then the zone 50 left or wanted to leave (partial state Z ₃ ).

Actions can thus be understood as a response to a combination of states, all of which must occur in order to trigger the specific action.

Individual states can also lead to a combination of actions. So z. B. when a blood leak alarm is detected, not only a message can be sent to the handheld device (as a first action of the combination of actions) but also an alarm sound on the blood treatment device (as a second action of the combination of actions).

List of reference symbols

1

extracorporeal blood circulation

2

Blood cassette

4th

Blood treatment device

5

Access device, such as an arterial connection needle

6

arterial patient hose clamp

7th

venous patient hose clamp

9

arterial section or arterial patient line or arterial blood collection line

11

Blood pump

13

Addition point for substituate (predilution)

14th

Addition point for substituate (post-dilution)

15th

arterial air-blood detector

17th

Feeding device, for example a substituate pump

17a

Substituate line

18th

automatic substituate port

19th

Blood filter

19a

Blood chamber

19b

Dialysate chamber

21st

venous air separation chamber

23

venous section or venous patient line or venous blood return line

23a

venous section

25th

venous substituate blood detector

26th

Compressed air source

27

Access device, such as a venous connection needle

29

Control and regulating device

31a

Dialysis fluid supply line

31b

Dialysate drain line

33a

Pressure sensor

33b

Pressure sensor

35

Single needle valve

36

Single-needle chamber

37

Pressure sensor

50

Zone

100

Storage device

200

Locking device

300

Receiving device

400

Execution device

1000

Surveillance system

Z ₁ , ..., Z _n

hygiene-relevant conditions

S ₁ , ..., S _n

Signal configurations

A ₁ , ..., A _n

Actions

B.

Data stream

C.

Data stream

D.

Data stream

E.

Data stream

F, F '

Data stream

U

Data stream

V24

Valve

V25

Valve

QUOTES INCLUDED IN THE DESCRIPTION

This list of the documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• WO 2009/118145 A1 [0060]
• WO 2011/116943 A1 [0060]
• WO 2008/123814 A1 [0060]
• WO 2003/086505 A1 [0060]

Claims (10)

Monitoring system (1000) for monitoring the occurrence of a state (Z _x ) (x = 1, ..., n) from a group of one or more predetermined states (Z ₁ , ..) related to the use of a blood treatment device (4). ., Z _n ), for which it was previously defined or determined that when they occur with the aim of avoiding contamination, cross-contamination or spreading of germs, predetermined actions (A _x ) are to be taken or brought about by the monitoring system (1000), whereby the Monitoring system (1000) comprises: - a storage device (100) in which the group of the predetermined states (Z ₁ , ..., Z _n ) is stored, and in which for each of these states (Z ₁ , ..., Z _n ) at least one predetermined configuration of a signal (S ₁ , ..., S _n ) and for each of these states (Z ₁ , ..., Z _n ) at least one predetermined action (A ₁ , ..., A _n ) in response to the signal (S ₁ , ..., S _n ) are assigned in this embodiment; - A detection device (200) configured to determine that or whether at least one of the states comprised by the group (Z ₁ , ..., Z _n ) has occurred, and further configured to generate a signal (S _x ) for this case that is assigned to the determined state (Z _x ) from the group to be sent in the assigned configuration; - a receiving device (300) configured for receiving the transmitted signal (S _x) and for causing a predetermined, this signal (S _x) associated with the action (A _x) by means of an execution device (400); and - execution means (400) configured for executing the the transmitted signal (S _x) associated with the action (A _x) upon receipt of the transmitted signal (S _x). Monitoring system (1000) according to Claim 1 wherein the execution device (400) - a monitor, screen or display for displaying a message corresponding to the signal (S _x ) to the user of the blood treatment device (4); and / or - a hand-held device which the user holds and / or carries with him as intended; and / or - is or has a control or regulating device (29) of the blood treatment device (4). Monitoring system (1000) according to Claim 1 or 2 , wherein the action (A _x ) is one or more actions of the following actions: Output of a predetermined information on a monitor, screen or display for the user; - Triggering a vibration alarm, an optical and / or an acoustic alarm; - Output of a note in, preferably multicolored, color representation; - Requesting confirmation from the user; and - storing a history which reproduces the times and / or the frequency of occurrence of messages, notices or alarms in connection with states (Z ₁ , ..., Z _n ) from the group. Monitoring system (1000) according to one of the preceding claims, wherein one or more of the following states applies as state (Z _x ): - the monitoring system (1000) detects that the user is from a predetermined zone (4) surrounding the blood treatment device (4) at least in sections ( 50) leaves; - The monitoring system (1000) recognizes that the user is or will be working, first one after the other, on a first and then on a second medical device, in particular on blood treatment devices (4), which are previously classified as hygiene-relevant; - The monitoring system (1000) recognizes a defined alarm condition; - The monitoring system (1000) recognizes a defined operating sequence step on the blood treatment device (4); - the monitoring system (1000) recognizes that the user is not wearing gloves; and - the monitoring system (1000) detects the entry of the user into a predetermined zone (50) surrounding the blood treatment device (4) at least in sections. Monitoring system (1000) according to one of the preceding claims, wherein the locking device (200) is or comprises: - any software or sections thereof; and or - a camera; and or - a sensor (15, 25, 33a, 33b, 37); and or - a touchscreen capacitance meter; and or - a zone monitoring device. System with a blood treatment device (4) and with a monitoring system (1000) according to one of the preceding claims. System according to Claim 6 wherein the blood treatment device (4) is configured to perform a hemodialysis, a hemofiltration, a hemodiafiltration or a separation process. Digital storage medium, in particular in the form of a floppy disk, CD or DVD or EPROM, with electronically readable control signals, configured to store a blood treatment device, which includes a storage device (100), a detection device (200), a receiving device (300), and an execution device (400 ) or is connected to it in signal communication, to a system according to Claim 6 to configure. Computer program product with a program code stored on a machine-readable carrier, configured to provide a blood treatment device, which has a storage device (100), a detection device (200), a receiving device (300), and an execution device (400) or is connected to this in signal communication , to a system according to Claim 6 to configure. Computer program with a program code to convert a blood treatment device, which has a storage device (100), a detection device (200), a receiving device (300), and an execution device (400), or is connected thereto in signal communication, to a system according to Claim 6 to configure.

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